Changzhou Hualian Health Dressing Co., Ltd. FDA Record
- Latest inspection NAI · May 12, 2025
- No warning letters matched by name
Changzhou Hualian Health Dressing Co., Ltd. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Changzhou Hualian Health Dressing Co., Ltd." is on file.
- Latest inspection
- May 12, 2025 · NAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 2 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 12, 2025 | Changzhou, China | Devices | No Action Indicated (NAI) | 3003807757 |
| Jan 29, 2015 | Changzhou, China | Devices | Voluntary Action Indicated (VAI) | 3003807757 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3003807757 | Changzhou, China | 2 | May 12, 2025 |
Changzhou Hualian Health Dressing Co., Ltd. and the FDA: common questions
Has Changzhou Hualian Health Dressing Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Changzhou Hualian Health Dressing Co., Ltd." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Changzhou Hualian Health Dressing Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Changzhou Hualian Health Dressing Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Changzhou Hualian Health Dressing Co., Ltd.?
The most recent FDA inspection on file ended May 12, 2025 at Changzhou, China and was classified NAI. FDA has 2 inspections of Changzhou Hualian Health Dressing Co., Ltd. on file.
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